BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW, W3 CANNULA (BDC)

    MDR report key: 183659 · Received August 20, 1998

    Report

    Report Number
    2939738-1998-00012
    Event Type
    Injury
    Date Received
    August 20, 1998
    Date of Event
    July 10, 1998
    Report Date
    July 20, 1998
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A SAPHENOUS VEIN HARVESTING PROCEDURE A PT'S LEG WOUNDS BECAME SEPTIC. THE SURGEON WAS UNSURE IF ANY OF ORIGIN'S PRODUCTS ACTUALLY CAUSED THE INFECTION. THE PT'S HOSPITAL STAY WAS PROLONGED FOR MONITORING PURPOSES. THE PT WAS LAST REPORTED IN CRITICAL CONDITION AND REMAINS HOSPITALIZED. THE HOSP IS CONDUCTING A CLOSED INVESTIGATION OF THE EVENT AND IS TESTING THE EXCISED TISSUE, ALL EQUIPMENT, TOOLS, STERILIZATION METHODS, ETC. FOR POSSIBLE SOURCES OF CONTAMINATION IN ADDITION TO ORIGIN PRODUCTS. ORIGINAL UNITS WERE DISPOSED OF BY THE HOSP STAFF. EIGHT UNUSED SAMPLES WERE RETURNED FOR EVALUATION, IN ADDITION THE SALES REP HAS RETURNED 16 UNUSED KITS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW, W3 CANNULA (BDC) VASOVIEW GCJ ORIGIN MEDSYSTEMS, INC. OMS-BDC 1506981

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R OTHER DEVICES USED DURING SURGERY: OMS-US,| OMS-BSZ, OMS-CD, OMS-BT12SL.